1. Field of the Invention
This invention relates to a method and apparatus for modifying a soft tissue structure underlying a skin surface, and more particularly to a method and apparatus which applies a mechanical force and electromagnetic energy to the soft tissue structure.
2. Description of Related Art
The correction of a deformity or the esthetic enhancement of a soft tissue structure is determined by the balance of the skin envelope as the container and soft tissue volume as the contents of the container. An appropriate balance between these two components is essential in achieving a successful outcome. Most plastic surgery procedures are based upon the resection or addition of a soft tissue filler with a concomitant modification of the skin envelope. For example, a breast that has three dimensional symmetry with the opposite breast must take into account both the volume of the soft tissue and the surface area of the breast envelope that is required as a container of the tissue. Breast reconstruction after mastectomy typically involves the insertion of a soft tissue replacement for the removed breast tissue. Either an implant or a tissue flap from the patient is used as a soft tissue replacement. Expansion of the breast skin envelope is also required and is achieved with a medical device called a breast expander. While most reconstructive procedures usually involve the addition of a soft tissue filler with the expansion of the skin envelope, many esthetic procedures involve the reduction of the soft tissue contents with or without a reduction in the skin envelope. Reduction in the volume of the soft tissue contents without a concomitant reduction in the skin envelope may lead to a relative excess of the skin envelope. The relative excess will be visualized as loose skin or elastosis. An example of esthetic enhancement is a procedure called breast reduction. This is performed in women who require reduction in the size of their breasts to alleviate shoulder, neck and back symptoms. Breast tissue is resected to reduce volume but also requires a reduction in the breast skin envelope with extensive surgical incisions. Without reduction of the skin envelope of the breast, severe ptosis (droopiness) of the breast will occur.
Another example is liposuction which may aggravate elastosis because the soft tissue content is reduced without reduction in the surface area of the skin envelope. The degree of esthetic contour reduction is limited by the preexisting looseness of the skin envelope. Typically, liposuction involves the removal of subcutaneous fat through a suction cannula inserted through the skin surface. Excess suctioning of fat will aggravate any preexisting elastosis. Any other modality that reduces subcutaneous fat through dieting or ablation of fat cells is likely to aggravate a preexisting elastosis if a concomitant reduction of the skin envelope does not occur. This is especially true in the hip and thigh area where a condition called xe2x80x9ccellulitexe2x80x9d is due to a preexisting looseness of skin. Many patients have a more severe looseness of skin in the hip and thigh area that would be aggravated by any fat removal. Skin tightening procedures that involve large surgical incisions result in severe scarring to the thigh and hip area that are a poor tradeoff to any esthetic contour reduction.
There is a need for a method and apparatus to achieve skin tightening without major surgical intervention. There is a further need for a method and apparatus to achieve skin tightening by the controlled remodeling of collagen in the skin and underlying fibrous partitions of the subcutaneous fat. Still a further need exists to tighten a skin envelop with minimal skin or underlying subcutaneous tissue cell necrosis. Yet another need exists to provide a method and apparatus for the controlled remodeling of collagen in tandem with subcutaneous fat ablation in which a net tightening of the skin envelope occurs with an esthetic contour reduction.
Accordingly, an object of the invention is to provide a method and apparatus to tighten skin.
Another object of the invention is to provide a method and apparatus to tighten skin without major surgical intervention.
Yet another object of the invention is to provide a method and apparatus to tighten skin with controlled remodeling of collagen.
A further object of the invention is to provide a method and apparatus that delivers a mechanical force and electromagnetic energy to a tissue site to change a skin surface.
A further object of the invention is to provide a method and apparatus that delivers a mechanical force and electromagnetic energy to a tissue site to change the contour of a soft tissue structure.
These and other objects of the invention are achieved in an apparatus to modify a skin surface or a soft tissue structure underlying the skin surface. A template has a soft tissue mechanical force application surface. The mechanical force application surface is configured to apply pressure to the soft tissue structure. An energy delivery device is coupled to the template. The energy delivery device is configured to deliver sufficient energy to the template to form a template energy delivery surface.
In one embodiment, a template means is configured to apply the mechanical force to the soft tissue structure at the mechanical force application surface. An energy delivery means is coupled to the template means and provides a controlled delivery of electromagnetic energy to the skin surface that does not exceed 1,000 joules/cm2 during a single treatment session. A combination of the mechanical force and the controlled delivery of electromagnetic energy changes a contour of the soft tissue structure.
In another embodiment, a method of operating an apparatus for modifying a structure provides an apparatus that includes a template means configured to receive a structure and apply a mechanical force. The apparatus also includes an energy delivery means coupled to the template means to provide a controlled delivery of electromagnetic energy to the structure not exceeding a dose rate of 10 joules/sec/cm2. Sufficient mechanical force and electromagnetic energy is delivered to the structure to remodel at least a portion of the structure.
The mechanical force application surface can be a positive pressure application surface that applies compression to the soft tissue structure or a negative pressure application surface that creates an extension of the soft tissue structure. Application of the mechanical force and delivery of the energy has a variety of different effects including but not limited to, (i) tightening the skin surface, (ii) smoothing the skin surface, (iii) improving a compliance of the skin surface, (iv) improving a flexibility of the skin surface, (v) remodeling of collagen in the soft tissue structure, (vi) cleaving collagen cross-links to remodel collagen, (vii) remodeling of collagen in the soft tissue structure with reduced cell necrosis, (viii) cleaving collagen cross-links and contracting a longitudinal axis of a collagen fibril, (ix) cleave collagen cross-links and extend a longitudinal axis of a collagen fibril, (x) cleaving collagen cross-links and shearing of a collagen fibril matrix, (xi) directing converging and diverging mechanical forces to the skin surface to smooth the skin surface and tighten the skin surface, (xii) directing converging and diverging mechanical forces to the soft tissue structure to create a three-dimensional contouring of the soft tissue structure, (xiii) creating a compressive force to collagen in the underlying soft tissue structure and (ix) delivering sufficient pressure and creating an extension force to collagen in the underlying soft tissue structure.
The mechanical force can, (i) create a compressive force to collagen in the underlying soft tissue structure, (ii) create an extension force to collagen in the underlying soft tissue structure and (iii) create a shearing force in the underlying soft tissue structure.